Device |
pediatric autism spectrum disorder diagnosis aid |
Regulation Description |
Pediatric Autism Spectrum Disorder diagnosis aid. |
Definition |
A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients. |
Physical State |
The device collects data based on the clinical presentation of a patient. An analysis algorithm is applied to the collected data. The device may be stand-alone or implemented as a software application on a smartphone or other general purpose computing platform. |
Technical Method |
Performs an analysis of patient behavioral data to aid in the diagnosis of Autism Spectrum Disorder. |
Target Area |
The device is intended to aid in the diagnosis of Autism Spectrum Disorder. |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | QPF |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
510(k)
|
Regulation Number |
882.1491
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |